Haloperidol
- Product NDC
- 69292-584
- 11-digit product format
- 692920584
- Labeler code
- 69292
- Product ID
- 69292-584_8c9cdd3d-9751-404a-9ceb-276e8dfa6391
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharmaceuticals, LLC
- Application
- ANDA071173
- Marketing category
- ANDA
- Marketing start
- 2022-04-18
- Substance
- HALOPERIDOL
- Active strength
- 2 mg/1
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071173-001 | HALOPERIDOL | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | |
| A071173-002 | HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | |
| A071173-003 | HALOPERIDOL | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | |
| A071173-004 | HALOPERIDOL | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | |
| A071173-005 | HALOPERIDOL | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | |
| A071173-006 | HALOPERIDOL | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071173-001 | AB |
| A071173-002 | AB |
| A071173-003 | AB |
| A071173-004 | AB |
| A071173-005 | AB |
| A071173-006 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A071173-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Haloperidol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HALOPERIDOL | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J6292F8L3D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9a9e20dd-646a-4fe9-a345-1b5bda8e7775 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d599bae4-cb25-0798-7468-31aa188fb750 | Product name | 7 | 20260304 |
| 6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e | Product name | 2 | 20250114 |
| af58e43a-5792-c2c1-8e57-a2454df1f2c0 | Product name | 3 | 20240202 |
| ce329990-eb12-45a5-87d5-ce5ef054ca71 | Product name | 2 | 20190930 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69292-584-01 | Haloperidol | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69292-584-01 | EA - Each | 69292-584 | d05e1b9e-8fed-4d03-9965-6b24cc0f8325 | 1 | 2022-05-04 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 861c7b75-572c-48c2-adf9-1ca3fc3db19b | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | a3afd19a-c340-4fad-8ddd-d71242515345 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 22598f07-501b-471a-b512-449d95e2301c | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 051f3c99-7d16-4185-a857-c90440e1b1c5 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | eb69959d-5967-41ac-a222-ff4416869dfc | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | b5a6c54c-fb70-4132-90ae-7d75b5e9c9de | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Innogenix, Inc. | 2c26af24-5ed3-4eb7-8d29-d6a019320a70 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 966db55f-3f12-4653-9668-1beff85df0ab | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 5f4d945e-97f0-4afc-88d6-9b55ec238686 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 9353117e-bd01-441a-b35f-fd1352c5df8c | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 457b8b71-8acf-47f1-93e5-1d353e53af10 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 2cffe2ad-3dad-479e-a91a-b41c3dd05ce1 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Coupler LLC | 38f59751-4741-f588-e063-6294a90a6528 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Method Pharmaceuticals, LLC | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 2025-06-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 490efba9-70f1-46b8-9d62-2f96163e25df | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | e8977803-08a2-4ad0-87d5-63d81c98a536 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Marlex Pharmaceuticals, Inc. | e7a61604-741f-2d3b-e053-2995a90a62fc | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | d9d0e530-02cd-4631-b3c8-cf6de521fd5b | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | df340d75-7387-4084-9d76-167283ee7462 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | d896823a-fb08-4777-a1f1-cef85fc8d96c | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69292-584-01 | 69292058401 | 100 TABLET in 1 BOTTLE (69292-584-01) | 100 tablet | 2022-04-18 | 0000-00-00 | No | No | Current |